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Medical Devices Regulatory Services in Japan
Artixio helps you meet PMDA requirements with end-to-end regulatory support for medical devices in Japan.
Artixio provides seamless regulatory services for commercialization of your medical device in the Japanese market. Our experienced professionals in Japan help you streamline the regulatory journey for your MedTech product. We assure timely compliance with the stringent guidelines the PMDA. Our dedicated team provides assistance right from product conceptualization till product surveillance.
Key Regulations for Medical Devices in Japan
- Pharmaceuticals and Medical Devices Act (PMD Act
- GMP (Good Manufacturing Practice
- Foreign Manufacturer Accreditation (FMA):
- Device Classification System
- Shonin and Ninsho Approvals
Artixio’s Medical Devices Registration Services in Japan

Why Artixio as your Medical device consultant in Japan?










FAQs
What is the Shonin process?
What is D-MAH?
Do medical devices sold in Japan should need product label in Japanese?
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